Trial Outcomes & Findings for Cognitive Stimulation (NCT NCT01271413)

Results Overview

Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

134 participants

Primary outcome timeframe

baseline, 7 weeks

Results posted on

2014-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Adaptive Cognitively Stimulating Activities Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.	Non-adaptive Cognitively Stimulating Activities Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
Overall Study STARTED	37	36
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitively Stimulating Activities n=28 Participants Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.	Cognitively Stimulating Activities: Other n=28 Participants Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.	Total n=56 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 8.8 • n=5 Participants	43.5 years STANDARD_DEVIATION 7.1 • n=7 Participants	43.4 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 7 weeks

Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks

Outcome measures

Outcome measures
Measure	Adaptive Cognitively Stimulating Activities n=28 Participants Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.	Non-adaptive Cognitively Stimulating Activities n=28 Participants Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
Working Memory	0.86 digits recalled Standard Deviation 1.21	0.04 digits recalled Standard Deviation 0.92

SECONDARY outcome

Timeframe: baseline, 7 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 7 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 7 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 7 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 7 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 7 weeks

Outcome measures

Outcome data not reported

Adverse Events

Cognitively Stimulating Activities

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitively Stimulating Activities: Other

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Miriam Mintzer

Johns Hopkins University School of Medicine

Phone: 410 550-0529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place